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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K952799
Device Name ABBOTT XL3M INFUSION PUMP
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK,  IL  60064
Applicant Contact DAVID T GUZEK
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK,  IL  60064
Correspondent Contact DAVID T GUZEK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/19/1995
Decision Date 01/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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